Senior Manager/Associate Director, Quality Assurance (14-119)FibroGen

THIS JOB HAS EXPIRED

Description:

FibroGen seeks a Quality Assurance Senior Manager/Associate Director to support the manufacture of Drug Substance and Drug Product at Contract Manufacturing Organizations (CMO) and Contract Research Organizations (CRO) to ensure FibroGen products are in compliance with Good Manufacturing Practices (GMP) and are of the appropriate quality for their intended use. The position involves managing quality operations with CMO/CRO, and liaison of quality related issues with FibroGen?s Chemistry, Manufacturing and Control (CMC) Team and functional areas.

The successful candidate must have the ability to execute QA tasks independently, effectively represent QA in CMC team setting, and interface with CMO/CRO.

10+ years of quality assurance background in pharma/biotech industry, with hands-on role in quality operations and quality systems
3+ years hands-on QA experience in working with CMO/CRO
B.S./M.S. in relevant science field
Quality control and/or analytical development background helpful
Small molecule synthesis and purification knowledge desirable
Familiarity with oral dosage forms (tablet, capsule) desirable
Working knowledge in CMC process a plus
Good interpersonal and writing skills
Self-motivated, independent, and collaborative
Some travel may be required